U.S. Food and Drug Administration, Silver Spring, Maryland.
J Womens Health (Larchmt). 2018 Jun;27(6):808-814. doi: 10.1089/jwh.2017.6760. Epub 2018 May 9.
Transcatheter aortic valve replacement (TAVR) is a less invasive alternative approach to surgery. Individual randomized clinical trials evaluating the safety and efficacy of TAVR were mostly underpowered for conducting separate analyses for women and men. We pooled data from premarket TAVR clinical trials comparing short (30 days)- and long-term (∼2 years) outcomes by sex.
Patient-level data from the TAVR arms of six clinical trials were pooled (2515 patients). Random-effects models for time-to-event outcomes (odds ratios [ORs] for 30-day outcomes and hazard ratios [HRs] for complete follow-up for mortality, ischemic stroke, kidney injury, major bleeding, myocardial infarction, and device migration) and dichotomous outcomes (ORs for reintervention, rehospitalization, and pacemaker implantation) were then fit to directly compare outcomes between women and men.
Overall, the pattern of individual comorbidities was more severe in men. There was no difference in mortality risk at 30 days (female-to-male OR = 1.00 [0.69-1.46]); however, at follow-up completion (∼2 years post-TAVR), women had a 24% lower mortality risk than men (HR = 0.76 [95% CI: 0.65-0.89]). Women also had a 30% lower risk of kidney injury at 30 days (OR = 0.70 [0.49-0.98]), which increased to 33% over the complete follow-up period (HR = 0.67 [0.51-0.87]). Major bleeding was more common in women compared to men at both 30 days (OR = 1.44 [1.19-1.76]) and long-term follow-up (HR = 1.22 [1.04-1.43]). For dichotomous outcomes, women had a 68% lower risk for reinterventions (OR = 0.32 [0.18-0.58]). We did not observe any difference in the risk of ischemic stroke, myocardial infarction, device migration, rehospitalizations, or pacemaker implantations between sexes.
This patient-level data meta-analysis of six premarket clinical trials found that women who received TAVR had fewer comorbidities at baseline. Acute outcomes (30 day) with respect to mortality were similar. Women were observed to have a lower risk of kidney injury, but higher risk of major bleeding compared to men receiving TAVR at 30 days. At complete follow-up, statistically significant advantages for women emerged in improved survival and lower reintervention risk. No differences in ischemic stroke, pacemaker implantation, or rehospitalization were observed. That women are healthier at baseline and develop fewer postprocedural complications than men may explain their higher survival.
经导管主动脉瓣置换术（TAVR）是一种侵袭性较小的手术替代方法。评估 TAVR 安全性和疗效的个别随机临床试验大多没有足够的能力对男性和女性进行单独分析。我们汇集了来自六个临床试验的 TAVR 臂的患者水平数据，这些数据比较了性别间的短期（30 天）和长期（约 2 年）结果。
汇总了六个临床试验的 TAVR 臂的患者水平数据（2515 例患者）。然后，使用时间到事件结果的随机效应模型（30 天结果的优势比 [OR] 和死亡率、缺血性卒、肾损伤、主要出血、心肌梗死和器械迁移的完整随访的危险比 [HR]）和二项结果（再介入、再住院和起搏器植入的 OR）直接比较男性和女性之间的结果。
总体而言，男性的个别合并症模式更为严重。30 天死亡率无差异（女性与男性的比值比 [OR] = 1.00 [0.69-1.46]）；然而，在随访结束时（TAVR 后约 2 年），女性的死亡率比男性低 24%（HR = 0.76 [95%CI：0.65-0.89]）。女性在 30 天时的肾脏损伤风险也降低了 30%（OR = 0.70 [0.49-0.98]），在整个随访期间增加了 33%（HR = 0.67 [0.51-0.87]）。与男性相比，女性在 30 天（OR = 1.44 [1.19-1.76]）和长期随访（HR = 1.22 [1.04-1.43]）时发生大出血的风险更高。与男性相比，女性在 30 天（OR = 0.32 [0.18-0.58]）和长期随访（OR = 0.32 [0.18-0.58]）时发生再介入的风险更低。我们没有观察到性别之间在缺血性卒、心肌梗死、器械迁移、再住院或起搏器植入方面存在任何差异。
这项对六项上市前临床试验的患者水平数据的荟萃分析发现，接受 TAVR 的女性在基线时合并症较少。关于死亡率的急性结果（30 天）相似。与接受 TAVR 的男性相比，女性在 30 天时发生肾脏损伤的风险较低，但发生大出血的风险较高。在完全随访时，女性的生存和降低再介入风险方面出现了统计学上的显著优势。没有观察到缺血性卒、起搏器植入或再住院的差异。女性在基线时更健康，术后并发症也更少，这可能解释了她们更高的生存率。
